MEDACTA RIGHT KNEE REPLACEMENT
Report
- Report Number
- MW5168965
- Event Type
- Injury
- Date Received
- April 14, 2025
- Date of Event
- October 3, 2022
- Report Date
- September 25, 2025
- Manufacturer
- MEDACTA USA, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
ADDITIONAL INFORMATION RECEIVED ON 8/18/2025 FOR REPORT MW5168965. I WRITE THIS LETTER IN THE HOPES MY SMALL VOICE REACHES YOU AND THAT I MAY BE ABLE TO ARTICULATE MY PERSONAL OPINION IN THIS SINCERE CORRESPONDENCE. I AM A SENIOR FEMALE RETIREE LIVING IN (B)(6). MY PERSONAL CONCERNS WITH OUR HEALTH SYSTEM AND RELATED ARTIFICIAL PRODUCTS IS TKR'S (TOTAL KNEE REPLACEMENTS). THERE ARE SEVERAL COMPANIES WHO MANUFACTURER THESE ITEMS FOR KNEES, HIPS, SHOULDERS THAT ARE DISTRIBUTED TO ORTHOPEDIC MEDICAL PROFESSIONALS. ALTHOUGH THE TECHNOLOGY IS UNIQUE, THE SUCCESS FROM PATIENTS IS VARIED. MY EXPERIENCE THE LAST SEVERAL YEARS HAVE BEEN MET WITH EVASIVE BEHAVIOR BY MY ORIGINAL SURGEON. IT IS VITALLY IMPORTANT THAT WHEN POST SURGICAL COMPLICATIONS OCCUR, THE HEALTH CARE PROFESSIONAL SHOULD IMMEDIATELY GRASP THE PROBLEM AND RESOLVE. IN MY CASE, MY SURGEON IGNORED MY SYMPTOMS AND DID NOTHING. WHAT WAS TO BE A "BETTER QUALITY OF LIFE" HAS TURNED OUT TO BE A NIGHTMARE. MY KNEE REPLACEMENTS FAILED AND I AM HIGHLY ALLERGIC TO THE WHICH HAD ENOUGH NICKEL TO AFFECT ME. THE WOUND WAS CLOSED BY STAPLES AND NOT DIS-SOLVABLE SUTURES THAT ALSO HAD AMOUNTS OF NICKEL. ALTHOUGH HESITANT, I FILED A COMPLAINT WITH (B)(6). UNFORTUNATELY, I WAS INFORMED BY THE HOSPITALS PATIENT ADVOCATE THAT THE SURGEON IS AN "INDEPENDENT CONTRACT" SURGEON AND THEY HOLD NO RESPONSIBILITY TO HIM. ADDITIONALLY, MY FAMILY AND I ATTEMPTED MEDIATION WITH DR. (B)(6) AND HE REFUSED. SENIORS AND RETIREES FACE UPHILL BATTLES WITH HEALTH CONCERNS WHETHER THROUGH MEDICARE AND/OR INSURANCE COMPANIES WHICH WE PAY EXTRA FOR. MEDICARE BENEFITS ARE DEDUCTED FROM SS BENEFITS EACH MONTH. IT IS ONLY THROUGH BEING ADVOCATES FOR OURSELVES THAT WE CAN DO OUR BEST TO INSIST ON ACCOUNTABILITY WITH THE DOCTORS WERE SEE. ANY LEGAL RECOURSE TAKEN RELIES SOLELY ON US. BEING A SENIOR FEMALE RETIREE DOESN'T MEAN WE LACK ENJOYING LIFE. PRIOR TO MY DISAPPOINTMENT OF MY SURGEON, I ENJOYED HIKING, RIDING MY BIKE, GARDENING. NOW I NO LONGER CAN SQUAT TO TIE MY SHOES, RIDE MY BIKE, KNEEL FOR GARDENING OR TAKE LONG HIKES AND KNEELING AT MY CHURCH TO WORSHIP IS ALSO VERY UPSETTING TO ME. I HAVE FILED A (ALMOST 18 MONTHS AGO) COMPLAINT TO THE (B)(6) STATE MEDICAL BOARD TO WHICH I EXERCISE PATIENCE WITH THE PENDING OUTCOME. THE COMPLAINT IS NOW WITH A MEDICAL REVIEW PANEL. FOLLOW UP INQUIRIES HAVE ALSO BEEN SENT TO THE FDA FOR BOTH RIGHT AND LEFT KNEE REPLACEMENTS. THERE MUST BE ACCOUNTABILITY FOR FAILED KNEE REPLACEMENTS WHETHER BY SURGEON OR MANUFACTURER. WHEN GHOSTING OCCURS BY A MEDICAL PROFESSIONAL, IT CASTS DOUBT OF HIS OR HER CAPABILITIES AS A SURGEON. DISSATISFACTION RATE FOR KNEE IMPLANTS IS RISING INCLUDING RECALLS. THE EVOLVING STUDIES AND VARYING TECHNOLOGY OF ARTIFICIAL IMPLANTS WILL SOMEDAY BE PERFECTED, BUT WE ARE NOT THERE YET, HOWEVER I AM TRYING TO REMAIN CAUTIOUSLY OPTIMISTIC TOWARDS THEIR ADVANCEMENT. EVERY PATIENT MAY NOT BE SUITABLE FOR IMPLANT TECHNOLOGY AND THIS NEEDS TO BE IDENTIFIED SOONER RATHER THAN LATER TO AVOID POST SURGICAL COMPLICATIONS. DR. (B)(6) IS ONE OF MANY ORTHOPEDIC SURGEONS IN OUR COUNTRY THAT DO NOT PERFORM PROPER PATIENT EVALUATION AND TESTING TO INSURE TKR'S ARE TL1E SUITABLE LONG TERM FOR THEIR PATIENTS. PROPER PATIENT SELECTION FOR MEDICAL IMPLANTS SHOULD BE MANDATORY. IT IS MY BELIEF THAT SURGEONS CAN LEARN SO MUCH FROM PATIENTS' COMPLICATIONS. TO MY POINT, I RECENTLY COMMUNICATED WITH MEDACTA USA, THE MANUFACTURER OF MY KNEE HARDWARE AND PROVIDED SERIAL NUMBERS AND PART NUMBERS. ALTHOUGH FULL DETERMINATION OF WHY MY IMPLANTS FAILED HAS NOT BEEN FULLY CLARIFIED. IN MY CASE, RANGE OF MOTION IS LIMITED AND PHYSICAL THERAPY IS NO LONGER AN OPTION. MEDACTA DID EXPRESS ATTENTIVENESS TOWARDS MY SITUATION BUT WITHOUT PROPER SURGEON FOLLOW UP, THIS ELUDES THEIR ABILITY TO CONTINUE TO IMPROVE THEIR MEDICAL DEVICES SOLELY BASED ON MY CONCERNS. DR. (B)(6) DID NOT INFORM THEM OF MY SITUATION AS THIS WOULD HAVE SURELY HELPED ME BOTH PHYSICALLY AND EMOTIONALLY AND HELPED WITH MY ONGOING RECOVERY. MEDACTA USA ALSO INFORMED ME THAT THEY WERE FOUNDED BY-A PATIENT WHO FELT THE NEED FOR FUTURE TECHNOLOGY AND RESEARCH FOR ARTIFICIAL IMPLANTS. MEDACTA APPEARS TO BE FLUID IN THEIR IMPLANT TECHNOLOGY AND WITH RECOGNIZING PATIENT EXPERIENCE BOTH POSITIVE AND NEGATIVE. THEY HAVE NOT BEEN TOTALLY SUCCESSFUL BUT DO PROTECT THEIR BRAND AS REVISION SURGERY HAS BEEN ACKNOWLEDGED. I HOPE MEDACTA HAS LEARNED FROM MY LESS THAN POSITIVE EXPERIENCE. IT IS EXTREMELY IMPORTANT THAT AGENCIES AND MANUFACTURES THAT OVERSEE PROPER SURGERY TECHNIQUES ENSURE THAT PATIENTS: COMPLETE FULL MEDICAL HISTORY AND EXAMINATION BY PRIMARY PHYSICIAN JOINTLY WITH ORTHOPEDIC SURGEON (NO MATTER WHAT GENDER, RACE AND AGE OF PATIENT). IMPLANT MANUFACTURER COORDINATION WITH SURGEON TO ENSURE PATIENT IS APPROPRIATE MATCH. FULL BLOOD PANEL, RADIOLOGY (ADVISE PATIENT THAT TRANSFUSIONS COULD BE NEEDED FOR EXCESSIVE BLEEDING). COMPLETE METAL TESTING BY AN EXPERIENCED IMMUNOLOGY AND ALLERGY CLINIC - OTHER METALS SUCH AS TITANIUM HAVE BEEN NOTED TO CAUSE ISSUES IN IMPLANTS. METAL TESTING WITH ORTHOPEDIC ANALYSIS ((B)(6)). PROPER SURGERY TECHNIQUES AND TRAINING (BY MANUFACTURER) FOR SPECIFIC IMPLANTS SO THAT ALL PATIENT PRE-OP REQUIREMENTS ARE MET. WARRANTY - LIFE SPAN OF IMPLANTS IS INCORRECT. MORE RESEARCH NEEDS TO BE PERFORMED. I SINCERELY HOPE AT SOME POINT, OUR HEALTH AND MEDICAL PROFESSIONALS IN OUR COUNTRY TAKE A STRONG LOOK AT MEDICAL HARDWARE WHETHER KNEES, SHOULDERS OR HIPS. A FOREIGN METAL IN OUR BODIES RUNS SEVERE RISKS AS IT HAS WITH ME. WE GET ONE CHANCE ON LIFE.
ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 10/20/2025 FOR REPORT #MW5168965. AS I CONTINUE TO PROVIDE YOU WITH DATA ON MY IMPLANT MATERIAL, I WAS RECENTLY CONTACTED BY MR. (B)(4) FROM MEDACTA INTERNATIONAL IN SWITZERLAND. ALTHOUGH HE WAS APOLOGETIC OF MY POST SURGICAL IMPLANT COMPLICATIONS, HE OFFERED NO ACCEPTANCE TO MY PROBLEM BUT WAS SURPRISINGLY INTERESTED IN MY KNOWLEDGE OF THE PAYMENTS MADE TO DR. (B)(6) FOR CONSULTATION FEES, TRAVEL AND EXPENSES. I HAVE ATTACHED YEAR TO DATE PAYMENT INFORMATION INCLUDING THE INCREASED AMOUNTS OVER THE YEARS SINCE AFFILIATED WITH MEDACTA, TOTALING $390,492.14 BEGINNING IN 2020. DURING THESE YEARS, DR. (B)(6) CONTINUED TO BE A CONSULTANT WITH MEDACTA KNOWING THE PRODUCT COULD HAVE A PROFOUND AFFECT ON HIS PATIENTS, HOWEVER, IGNORED DUE TO HIS FINANCIAL INVESTMENT AND GREED. WHEN FIRST CONTACTED BY MEDACTA (B)(4) IN THEIR USA OFFICE AND AFTER SEVERAL FAILED ATTEMPTS, THE PRODUCT INFORMATION AND MEDACTA'S RELATIONSHIP INFORMATION WAS NOT DISCLOSED. THIS IS A DIRECT CONFLICT AND THEY SHOULD HAVE BEEN AWARE OF THE RELATIONSHIP WITH THE SURGEON AND I. SHAME ON THEM. MEDACTA IS WORTH 3.88 BILLION DOLLARS AND YET THEIR SO-CALLED LIFETIME KNEE REPLACEMENT PROGRAM APPARENTLY WAS NOT COMMUNICATED. MEDACTA ALSO HAS A PROGRAM OFFERING PATIENTS UP TO $5,000 EACH FOR FAILURES. I WAS TOLD I DID NOT QUALIFY BECAUSE IT WAS A NEW PROGRAM. REALLY ? IT SEEMS THERE HAVE BEEN OTHER FAILED MEDACTA IMPLANTS AND A PRECEDENT HAS BEEN SET BY THEM. MR. (B)(4) SAID THERE "COULD BE" A "PLAN" FOR MY PROBLEM BUT THAT HE COULD ONLY DO "SO MUCH" AND WOULD MEET WITH HIS TEAM. MR. (B)(4) ALLEGES HE IS READY AND PREPARED FOR ANY FDA INVESTIGATION AND HE "HAS WHAT HE NEEDS" - HE DOES NOT HAVE "ALL" WHAT HE NEEDS AND IS NOT PRIVILEGED PER MY HIPPA RIGHTS. AS MY MEDICAL REVIEW GOES FORWARD WITH THE STATE OF (B)(6), I AM HOPEFUL FOR JUSTICE. BOTH IMPLANT MANUFACTURES AND NEGLECTFUL SURGEONS SHOULD BE HELD ACCOUNTABLE. MEDACTA OFFERED ME NO COMPENSATION HOWEVER HAS DONE SO WITH OTHER PATIENTS. NEXT STEPS WOULD BE CIVIL SUIT AND/OR INCLUDING PRODUCT LIABILITY. I THANK YOU FOR YOUR CONTINUED INVESTIGATION. I DON'T INTEND TO BACK DOWN AGAINST THESE BUSINESSES. THE CONSUMER LIKE ME ULTIMATELY PAYS THE PRICE FOR NEGLECT BY BOTH PARTIES INVOLVED. PT CODE: 4580. DEVICE CODE: 3190.
I WAS EVALUATED FOR KNEE PAIN BY DR. (B)(6). ORTHOPEDIC SURGEON IN (B)(6) IN 2022. RADIOLOGY FILMS WERE TAKEN AND I WAS INSTRUCTED THE "ONLY" WAY TO REPAIR MY KNEES WAS WITH TOLA] KNEE REPLACEMENT. I ASKED SEVERAL QUESTIONS, ESPECIALLY AT THAT TIME A WOMEN IN MY EARLY 70'S - I ASKED IF I WOULD HAVE A REACTION TO THE METAL USED AND THAT AT THE TIME WAS NOT AWARE OF ALLERGIES. REQUESTED THAT AN ALLERGY TEST BE DONE TO BE SURE. MY REQUEST WAS DENIED AND DR. (B)(6) WAS ADAMANT I WOULD NOT HAVE ANY POST-SURGICAL COMPLICATIONS. THE RIGHT KNEE WAS PERFORMED FIRST. DR. (B)(6) USED A PRODUCT BY MEDACTA. I IMMEDIATELY HAD COMPLICATIONS WITH SEVERE PAIN, STIFFNESS, MOBILITY ISSUES, INSTABILITY DUE TO JOINT LOOSENING, DISLOCATION, SWELLING AND INFLAMMATION, WARMTH AND REDNESS. THE REASONS FOR SECOND (DR. (B)(6)) AND THIRD OPINIONS (DR. (B)(6)) WAS DUE TO ALL THE SYMPTOMS NOTED ABOVE INCLUDING CELLULITIS AROUND INCISION TREATED WITH ANTIBIOTICS (DR. (B)(6) REFUSED TO TREAT) I WAS REFUSED PHYSICAL THERAPY BY DR. (B)(6) BUT INSTEAD WAS GIVEN HOME EXERCISES THAT I PERFORMED TO NO AVAIL. I WAS GIVEN TO KNEE MANIPULATIONS ON THE RIGHT KNEE AND STILL MY MOBILITY IS LIMITED. THE LEFT KNEE WAS PERFORMED (B)(6) 2022 WHICH WORSE POST OP SYMPTOMS WERE EVIDENT -AFTER A SECOND OPINION I PAID FOR ORTHOPEDIC ANALYSIS OF CHICAGO TO TEST MY HARDWARE. I FOUND I WAS HIGHLY ALLERGIC TO THE IMPLANTS - AFTER 40 PLUS PHYSICAL THERAPY SESSIONS THAT MY PRIMARY PHYSICIAN (DR. (B)(6)) REQUESTED WAS TO NO AVAIL SO I OBTAINED A RENOWNED ORTHOPEDIC SURGEON THROUGH (B)(6) DETERMINED THAT I WAS NOT ONLY ALLERGIC TO THE KNEE IMPLANTS BUT THEY WERE ALSO LOOSE AND MISALIGNED - IT WAS VERY IMPORTANT A REVISION BE DONE - ON (B)(6) 2024 (B)(6) REMOVED THE DEFECTIVE IMPLANT AND NICKEL COMPONENTS. I WILL NEVER HAVE THE QUALITY OF LIFE THAT THE TOTAL KNEE REPLACEMENTS ARE SAID TO BE THE PROPER TREATMENT. I AM SINCERELY DISAPPOINTED IN THE QUALITY CONTROL OF THESE ITEMS. AS OF TODAY, I AM TRYING TO GET MORE INFORMATION ON THE PRODUCT FROM MEDACTA. MY CORRESPONDENCE TO THEM AND PHONE CALLS GO BACK TO 2024. AT THE ADVICE OF PATIENT ADVOCATE AT (B)(6) HOSPITAL WHERE THE SURGERIES WERE PERFORMED, THEY SUGGESTED I REPORT DR. (B)(6) TO THE STATE OF (B)(6) MEDICAL BOARD. MY CASE HAS BEEN ONGOING SINCE (B)(6) 2024. I RECENTLY FOUND OUT MY CASE IS NOW WITH MEDICAL EXAMINERS. I AM FRUSTRATED AND FEEL THE MANUFACTURES OF THESE PRODUCTS NEED TO BETTER PATIENT TESTING. I HAVE REACHED OUT TO MEDACTA AND L HAVE BEEN UNSUCCESSFUL IN REACHING THEM BY PHONE AND BY CERTIFIED LETTERS. I AM BEING IGNORED. I NEED TO KNOW IF MY PRODUCT IS A RECALL OR OTHER DEFECTIVE COMPONENTS. I HAVE THAT RIGHT TO KNOW AND BE INFORMED. IMPLANT DATE: (B)(6) 2022. REF REPORT: MW5168966.
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 8/26/2025 FOR REPORT MW5168965. THANK YOU FOR ACCEPTING MY COMPLAINT FOR THE ATTACHED MEDICAL DEVICES AKA MEDACTA TOTAL KNEE REPLACEMENTS. I UNDERSTAND THAT I MAY NOT REQUEST UPDATES ON THE INVESTIGATION, HOWEVER, MAY CONTINUE TO INFORM YOU OF CHANGES TO MY COMPLAINT. THE CONTINUED ISSUES I HAVE ARE ONGOING AND I AM NOW PHYSICALLY DISABLED ON MEDACTA IMPLANTS ONLY 3 YEARS OLD. I AM NOW ON DAILY MAINTENANCE OF MELOXICAM. AS PREVIOUSLY NOTED IN MY ORIGINAL COMPLAINTS, THE SURGEON WHO PERFORMED WAS DR. (B)(6) WHO I HAVE ALSO INFORMED YOU HAS BEEN REPORTED TO THE (B)(6) MEDICAL BOARD. WHEN IMMEDIATE POST-SURGICAL COMPLICATIONS AROSE, HE ABANDONED ME AS HIS PATIENT WITHOUT NOTIFICATION. THE SURGEON TOOK AN OATH TO TREAT AND HEAL AND DID NEITHER. IN MANY ATTEMPTS THROUGH MEDACTA, (B)(6), I WAS GIVEN VARY VAGUE INFORMATION ON MY SERIAL NUMBERS OF MY IMPLANTS. COMMUNICATION AT TIMES WAS DISTANCED AND LETTERS RETURNED. I AM IN THE KNOWLEDGE THAT MEDACTA HAS BEEN IN CONTACT WITH DR. (B)(6). I AM NOW BEING IGNORED BY MEDACTA. IT IS IMPERATIVE ADDITIONAL COMPONENT INFORMATION IS NEEDED SO I MAY CONSULT A MEDICAL SOURCE TO AID WITH MY PERMANENT ISSUES. MEDACTA INFORMATION IS INVASIVE ALTHOUGH THEY HAVE GENERATED PROGRAMS FOR REIMBURSEMENT FOR FAILED IMPLANTS. THEY HAVE INFORMED ME I DO NOT QUALIFY AND IT SHOULD BE HANDLED THROUGH THE ORIGINAL SURGEON. MEDACTA ADVISES AND CONSULTS WITH NUMEROUS ORTHOPEDIC SURGEONS TO BETTER ENHANCE THEIR PRODUCTS WHICH IS A BILLION-DOLLAR INDUSTRY. THROUGH OPEN PAYMENTS, IT HAS BEEN FOUND THAT DR. (B)(6) WAS PAID IN 2024, (B)(6) FOR CONSULTING FEES, TRAVEL AND LODGING AND FOOD AND BEVERAGE WITH CONSULTING FEES RESULTING IN NEARLY(B)(6). DR. (B)(6), WHO IS PART OF DR.(B)(6) OFFICE ALSO RECEIVED AND ENORMOUS FEES IN ADDITION TO HIS REGULAR PRACTICE OF SURGERY. IT APPEARS AT ANY TIME, MEDACTA AND/OR HIS MEDICAL TEAM SHOULD HAVE BEEN AWARE OF PATIENT DISSATISFACTION AND POST-SURGICAL ISSUES. I AM ALLERGIC TO MY IMPLANTS AND STILL REQUIRE A BETTER UNDERSTANDING OF THE HARDWARE IN MY BODY. BOTH MEDACTA AND DR. (B)(6) SHOULD BE ACCOUNTABLE. THIS IS AN IMMENSE CONFLICT OF INTEREST WITH NO CARE FROM EITHER ABOUT THEIR PATIENT. THE DISSATISFACTION WITH IMPLANTS IS RISING AND PATIENTS WHO BECOME PERMANENTLY DISABLED SHOULD BE ALLOWED CLAIMS AGAINST THE MANUFACTURER. I APPRECIATE YOUR ADDING THIS INFORMATION TO MY DATABASE PROFILE. I HAVE FORWARD HARD COPIES TO MEDACTA AND (B)(6) MEDICAL BOARD. THIS IS A HORRIFIC SITUATION AND ADVOCATE FOR BETTER PATIENT CARE. I HOPE TO CONVEY MY CONCERNS TO THE AARP FORUM SO NO ADULT WHETHER SENIOR OR NOT, WILL EVER GO THROUGH THIS NEGLECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114082 | MEDACTA RIGHT KNEE REPLACEMENT | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | MEDACTA USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Hospitalization| R| S | AMLODIPINE| ATAVASTATIN| BABY ASPIRIN | LEVOTHYROXIN| MELOXICAM (KNEE SWELLING)| VALSARTIN |