inforMED
InjuryJWH

TRIATHLON KNEE REPLACEMENT

Received Jun 11, 2026 · Event occurred Oct 16, 2024

Report MW5189350 · MDR key 25473025

Device

Generic name

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal

Patient

64 YR · Female

  • Fever
  • Hypersensitivity/Allergic reaction
  • Failure of Implant
  • Loss of Range of Motion
  • Chills
  • Ambulation or Postural Difficulties
  • Implant Pain
  • Swelling/ Edema

Narrative

Description of Event or Problem

ON (B)(6) 2024, I HAD A ROBOTIC TOTAL LEFT KNEE REPLACEMENT PROCEDURE AND THE IMPLANTED DEVICE WAS THE STRYKER TRIATHLON TKA SYSTEM. AFTER THE SURGERY, I HAD A FEVER, CHILLS, SEVERE PAIN, AND OVERALL I WAS FEELING VERY UNWELL. AFTER SURGERY, I FOLLOWED UP WITH ALL PHYSICAL THERAPY APPOINTMENTS AND ALL APPOINTMENTS WITH MY SURGEON'S PA, AND FINALLY GOT TO SEE THE SURGEON AT 3 MONTHS POST-OP. DURING THE 5-6 MONTHS FOLLOWING SURGERY, I WAS STILL EXPERIENCING SO MUCH PAIN, DISCOMFORT, AND SWELLING THAT IT PREVENTED ME FROM HAVING EVEN THE MOST MINIMAL RANGE OF MOTION AND MOBILITY IN MY LEFT KNEE. THE SURGEON SAID HE COULD NOT FIGURE OUT WHY I WAS IN SO MUCH PAIN AND WAS HAVING SO MANY ISSUES. ALSO AT ABOUT THE 5 MONTH MARK POST-OP, I STARTED BREAKING OUT WITH A SKIN RASH OVER MY ENTIRE BODY. I DID RESEARCH ON THE STRYKER DEVICE THAT WAS USED AND FOUND THAT IT HAS HAD A HISTORY OF CAUSING SYMPTOMS LIKE WHAT I HAVE BEEN EXPERIENCING BECAUSE IT CONTAINS NICKEL, TO WHICH I AM ALLERGIC. MY SURGEON AND HIS STAFF WERE ALSO INFORMED PRIOR TO MY KNEE REPLACEMENT SURGERY THAT I DO IN FACT HAVE A HISTORY OF NICKEL ALLERGY AND THAT I HAD BEEN HOSPITALIZED YEARS PRIOR FOR CELLULITIS RELATED TO A NICKEL JEWELRY EXPOSURE. DUE TO MY SYSTEMIC RASH AND CONSTANT ITCHING, PAIN, AND DISCOMFORT FOLLOWING MY KNEE REPLACEMENT SURGERY, I DECIDED TO CONSULT WITH AN ALLERGIST. THE ALLERGIST STATED THAT IT IS POSSIBLE THAT THE NICKEL MAY BE CAUSING THE SYSTEMIC AND CHRONIC SKIN RASH. HE ALSO SAID THAT PATIENTS FOR THESE DEVICE IMPLANTS ARE USUALLY SENT TO HIM PRIOR TO THEIR JOINT REPLACEMENT SURGERY FOR ALLERGY TESTING FOR METAL ALLERGIES. I WAS NEVER SENT FOR ALLERGY TESTING PRIOR TO MY SURGERY THOUGH I REPORTED MY NICKEL ALLERGY TO MY SURGEON AND HIS OFFICE STAFF PRIOR TO MY KNEE REPLACEMENT SURGERY. NEXT, I WAS GIVEN A DUPIXANT INJECTION BY THE ALLERGIST FOR THE CHRONIC, SYSTEMIC RASH THAT I WAS DEALING WITH. MY ORTHOPEDIC DOCTOR STATED TO ME AND MY HUSBAND THAT AFTER MY PROCEDURE, BECAUSE OF THE ISSUES I HAVE BEEN EXPERIENCING, HE DID CONFIRM WITH THE STRYKER SALES REP THAT THE DEVICE COULD HAVE A SMALL AMOUNT OF NICKEL FROM THE MANUFACTURING PROCESS. I AM CONVINCED THAT MY BODY IS REJECTING THE DEVICE AND THAT I NEED TO HAVE IT REPLACED WITH CERAMIC. NEITHER MY SURGEON, NOR THE HOSPITAL HAS HELPED ME TO GET RESOLUTION REGARDING MY IMMOBILITY, PAIN, AND RASH OVER MY ENTIRE BODY (AND WITH THE POSSIBLE NEED FOR EXPLANTATION OF MY NICKEL KNEE IMPLANT). I CONTINUE TO HAVE MINIMAL RANGE OF MOTION IN MY LEG/KNEE, I HAVE LOST MY EMPLOYMENT DUE TO THIS DISABILITY, MY INSURANCE HAS LAPSED, THE DUPIXANT ALLERGY SHOT IS WEARING OFF, AND THE CHRONIC, SYSTEMIC RASH OVER MY ENTIRE BODY IS STARTING AGAIN. ALL OF THESE ISSUES HAVE BEEN REPORTED TO MY SURGEON, THE HOSPITAL, THE ALLERGIST, AND APPARENTLY TO THE STRYKER SALES REP BY THE SURGEON, BUT I CANNOT SEEM TO GET RESOLUTION FOR MY CONDITION FROM ANYONE EVEN THOUGH I REPORTED MY ALLERGIES PRIOR TO MY SURGERY. I FOLLOWED ALL PHYSICAL THERAPY DIRECTION AND I FOLLOWED ALL SURGEON AND ALLERGIST TREATMENT RECOMMENDATIONS. ALL I WANT IS FOR THE SURGEON TO MAKE THINGS RIGHT AND RE-IMPLANT A CERAMIC OR NICKEL FREE IMPLANT SO I CAN BEND MY KNEE AGAIN AND GET BACK TO GOOD HEALTH WITHOUT PAIN, SWELLING, ITCHING, AND A RASH COVERING MY ENTIRE BODY. ONE FINAL NOTE, A REPRESENTATIVE FROM THE ANTHEM INSURANCE COMPANY (THE INSURANCE PROVIDER THAT I HAD THROUGH WORK FOR MY JOB WHILE I WAS STILL EMPLOYED AT (B)(6), INFORMED ME THAT THEY WOULD APPROVE A RE-OPERATION TO EXPLANT MY CURRENT IMPLANT THAT MAY CONTAIN NICKEL TO SUBSEQUENTLY REIMPLANT A NICKEL-FREE CERAMIC IMPLANT IF A HOSPITAL H.R. EMPLOYEE BENEFITS COORDINATOR FROM (B)(6) WOULD APPROVE THIS PLAN OF CARE. THE HOSPITAL REPRESENTATIVE AT (B)(6) DENIED THE REQUEST FOR REOPERATION.